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Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
Open accessAbstract
OBJECTIVE: The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures. METHODS: All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy. RESULTS: The average participant was 34 (±11.4) years old with epilepsy for 19.6 (±11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%). CONCLUSIONS: The RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years.
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“Recent studies on patients implanted with this device have exhibited significant reductions in seizures over a sustained period of time, and hence, the patients experience an improved quality of life [8].”
From Implantable neurotechnologies: a review of integrated circuit neural amplifiers (2016) · cites this paper as [8]
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Metadata
- Authors
- Bergey, G. K., Morrell, M. J., Mizrahi, E. M., Goldman, A., King-Stephens, D., Nair, D., Srinivasan, S., Jobst, B., Gross, R. E., Shields, D. C., Barkley, G., Salanova, V., Olejniczak, P., Cole, A., Cash, S. S., Noe, K., Wharen, R., Worrell, G., Murro, A. M., Edwards, J., Duchowny, M., Spencer, D., Smith, M., Geller, E., Gwinn, R., Skidmore, C., Eisenschenk, S., Berg, M., Heck, C., Van Ness, P., Fountain, N., Rutecki, P., Massey, A., O'Donovan, C., Labar, D., Duckrow, R. B., Hirsch, L. J., Courtney, T., Sun, F. T., & Seale, C. G.
- Affiliations
- Johns Hopkins University (US)
- Stanford University (US)
- Baylor College of Medicine (US)
- Author affiliations are provided at the end of the article.
- Cleveland Clinic (US)
- Columbia University (US)
- Dartmouth College (US)
- Emory University (US)
- George Washington University (US)
- Henry Ford Health (US)
- Indiana University Bloomington (US)
- Louisiana State University (US)
- Harvard University (US)
- Mayo Clinic (US)
- Augusta University (US)
- Medical University of South Carolina (US)
- Oregon Health & Science University (US)
- Rush University (US)
- Swedish Medical Center (US)
- Thomas Jefferson University (US)
- University of Florida (US)
- University of Rochester (US)
- University of Southern California (US)
- University of Virginia (US)
- University of Wisconsin–Madison (US)
- Cornell University (US)
- Yale University (US)
- Corresponding author
- Morrell, Martha J.
- ORCID
- Bergey, Gregory K.
- Morrell, Martha J.
- Goldman, Alica
- Nair, Dileep
- Jobst, Barbara
- Gross, Robert E.
- Shields, Donald C.
- Salanova, Vicenta
- Cole, Andrew
- Cash, Sydney S.
- Noe, Katherine
- Wharen, Robert
- Worrell, Gregory
- Edwards, Jonathan
- Duchowny, Michael
- Spencer, David
- Smith, Michael
- Gwinn, Ryder
- Skidmore, Christopher
- Eisenschenk, Stephan
- Fountain, Nathan
- Rutecki, Paul
- Hirsch, Lawrence J.
- Seale, Cairn G.
- Venue
- Neurology
- Published
- 2015-02-24
- Volume
- 84
- Issue
- 8
- Pages
- 810-817
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC4339127
- OpenAlex
- W2119130526
- Cited by
- 634
- References
- 45
- Citations by year
- 2026: 32 · 2025: 43 · 2024: 60 · 2023: 42 · 2022: 52 · 2021: 55 · 2020: 76 · 2019: 71 · 2018: 74 · 2017: 49 · 2016: 53 · 2015: 26
- FWCI
- 54.34
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Neurology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Massachusetts General Hospital
- Yale University
- University of Southern California
- Emory University
- George Washington University
- Wake Forest University
- Cleveland Clinic
- Cleveland Clinic Foundation
- Johns Hopkins University
- University of Rochester
- Louisiana State University
- Dartmouth College
- Thomas Jefferson University
- Rush University
- University of South Carolina
- School of Medicine, Indiana University
- Topics
- Health Sciences › Medicine › Clinical Neurology › Epilepsy research and treatment
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
- Keywords
- responsive neurostimulation, refractory partial seizures, epilepsy, seizure reduction, long-term efficacy, device safety, implant site infection, quality of life, seizure foci
- MeSH terms
- Adolescent, Adult, Aged, Double-Blind Method, Epilepsies, Partial, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, Deep Brain Stimulation, Young Adult
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